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| ID | Type | Description | Link |
|---|---|---|---|
| WI217662 | Other Identifier | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Korean Cancer Study Group | OTHER |
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This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib + Tamoxifen ± Goserelin | Experimental | Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) |
|
| Placebo + Tamoxifen ± Goserelin | Active Comparator | Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first. | Baseline up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from date of randomization to date of death due to any cause. | From the randomization of the last patient up to 3 years |
| Survival Probabilities at 1 year, 2 year, and 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kan Yonemori, MD, PhD | Department of Breast and Medical Oncology, National Cancer Center Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| National Cancer Center Hospital East |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42340618 | Derived | Yamanaka T, Sohn J, Sudo K, Mukai H, Yamamoto N, Chung CF, Lu YS, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Noguchi E, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. Quality of life with palbociclib plus tamoxifen in hormone receptor-positive, HER2-negative advanced breast cancer: results from PATHWAY, an Asian international, double-blind, randomized phase 3 trial. Breast Cancer. 2026 Jun 24. doi: 10.1007/s12282-026-01865-0. Online ahead of print. | |
| 39174547 |
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|
| Placebo | Drug | Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment |
|
| Tamoxifen | Drug | Tamoxifen, 20mg, orally once daily (continuously) |
|
| Goserelin | Drug | For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks |
|
The probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate.
| From the randomization of the last patient up to 3 years |
| Objective Response (OR) | Complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1 recorded from randomization until disease progression or death due to any cause. | Baseline up to 3.5 years |
| Duration of Response (DR) | The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. | Baseline up to 3.5 years |
| Clinical Benefit Response (CBR) | CR or PR or SD >=24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death of any cause. | Baseline up to 3.5 years |
| Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores | The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant. | Baseline up to 3.5 years |
| Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores | The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning. | Baseline up to 3.5 years |
| Trough plasma concentrations of palbociclib | Ctrough for palbociclib | Cycle 1/Day 15 and Cycle 2/Day 15 |
| Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen | Ctrough for tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen | Cycle 2/Day 15 and Cycle 3/Day 15 |
| Treatment-Emergent Adverse Events | From the first dose of the investigational product until 28 days after the last dose of study drugs |
| Kashiwa |
| Chiba |
| 2778577 |
| Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 7910280 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 0030804 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 6738558 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 2418515 | Japan |
| Kindai University Hospital | Ōsaka-sayama | Osaka | 5898511 | Japan |
| Toranomon Hospital | Minato-Ku | Tokyo | 1058470 | Japan |
| Chiba Cancer Center | Chiba | 2608717 | Japan |
| Kyusyu Cancer Center | Fukuoka | 8111395 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 5400006 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| National University Hospital | Singapore | 119882 | Singapore |
| National Cancer Centre Singapore | Singapore | 169610 | Singapore |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Ajou University Hospital | Gyeonggi-do | 16499 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Severance Hospital, Yonsei University Health System | Soeul | 03722 | South Korea |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Vetarans General Hospital | Taipei | 11217 | Taiwan |
| Sun Yat-Sen Cancer Center | Taipei | 11259 | Taiwan |
| Derived |
| Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Aug 22;10(1):76. doi: 10.1038/s41523-024-00684-w. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D013629 | Tamoxifen |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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